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RegisterSimilar dissolution rate but Failed BE study [Dissolution / BCS / IVIVC]
- Effect of food on the excipients of the test product resulting in a drastic change in the bioavailability of the test and ref product? Solubility issue?
- Have you looked at the individual subject data? Any weirdos? With sample size so small this might be a problem...
John
Complete thread:
- Similar dissolution rate but Failed BE study wanabby 2012-09-26 03:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS II… Helmut 2012-09-26 14:20
- Similar dissolution rate but Failed BE studyjag009 2012-09-27 21:29
- Excipients Helmut 2012-09-29 14:00
- Excipients jag009 2012-10-01 22:35
- test or reference? Helmut 2012-10-02 19:58
- Excipients jag009 2012-10-01 22:35
- Excipients Helmut 2012-09-29 14:00
- Similar dissolution rate but Failed BE study ElMaestro 2012-10-01 23:06
Ing. Helmut Schütz